Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
Overview[ - collapse ][ - ]
| Purpose | This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study: - The frequency of treatment related adverse events. - The frequency of efficacy assessment. - Treatment related unlisted adverse events in Japanese Package Insert. - Risk factors likely to affect the frequency of treatment related adverse event. |
|---|---|
| Condition | Epilepsies, Partial |
| Intervention | Drug: gabapentin |
| Phase | Phase 4 |
| Sponsor | Pfizer |
| Responsible Party | Pfizer |
| ClinicalTrials.gov Identifier | NCT01441401 |
| First Received | September 23, 2011 |
| Last Updated | April 24, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 23, 2011 |
|---|---|
| Last Updated Date | April 24, 2014 |
| Start Date | October 2011 |
| Estimated Primary Completion Date | May 2015 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan) |
|---|---|
| Official Title | Special Investigation of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan) |
| Brief Summary | This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study: - The frequency of treatment related adverse events. - The frequency of efficacy assessment. - Treatment related unlisted adverse events in Japanese Package Insert. - Risk factors likely to affect the frequency of treatment related adverse event. |
| Detailed Description | All the patients whom an investigator prescribes the first gabapentin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random. |
| Study Type | Observational |
| Study Phase | Phase 4 |
| Study Design | Observational Model: Case-Only, Time Perspective: Prospective |
| Condition | Epilepsies, Partial |
| Intervention | Drug: gabapentin According to Japanese Package Insert: For infants and children aged 3 to 12 years, a daily dosage of 10 mg/kg of gabapentin should be administered orally in 3 divided doses on the first day of treatment, and an effective dosage of 20 mg/kg should be administered to them in 3 divided doses on day 2. From day 3 on, infants aged 3 to 4 years should be maintained on the dosage of 40 mg/kg, and children aged 5 to 12 years on the dosage of 25 to 35 mg/kg administered orally in 3 divided doses, respectively (the maximum daily dosage: 1800 mg). Though the maintenance dosage may be adjusted depending on the patient's condition, the maximum daily dosage should be 50 mg/kg. At any time point, dosage should not exceed that the dosage for adults and children aged 13 years.As for children aged 13 years or over is as same as administration for adult. |
| Study Arm (s) | Gabapentin Peadiatric subjects taking Gabapen Tablets and syrup. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Enrolling by invitation |
|---|---|
| Estimated Enrollment | 300 |
| Estimated Completion Date | May 2015 |
| Estimated Primary Completion Date | May 2015 |
| Eligibility Criteria | Inclusion Criteria: - All the pediatric subjects (aged 3-15 years) whom an investigator prescribes the first gabapentin (tablets, syrup, and switch to syrup from tablet) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random. Exclusion Criteria: - Patients who have been enrolled in the drug use investigation of Gabapen tablets in adults (protocol No. A9451163). - Patients who receive Gabapen tablets or syrup before, except for switched from tablets to syrup. |
| Gender | Both |
| Ages | 3 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01441401 |
|---|---|
| Other Study ID Numbers | A9451175 |
| Has Data Monitoring Committee | No |
| Information Provided By | Pfizer |
| Study Sponsor | Pfizer |
| Collaborators | Not Provided |
| Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
| Verification Date | April 2014 |